Comparative Efficacy and Safety of Daily Versus Alternate-Day Dosing of Rosuvastatin in Diabetic Dyslipidemia: An Open-Label Clinical Trial.

BACKGROUND

Cardiovascular disease (CVD) is a growing health concern among individuals with diabetes. Cardiovascular conditions tend to present earlier in Indian populations, and the prevalence of diabetes is increasing in the region. Type 2 diabetes (T2DM) is frequently linked to abnormal cholesterol (CH) levels, which can increase the risk of heart problems. Rosuvastatin is a medication often used to manage cholesterol and may offer dosing flexibility due to its long duration of action.

AIMS AND

OBJECTIVES

To compare the efficacy and safety of daily versus alternate-day dose of rosuvastatin in patients with T2DM.

MATERIALS AND

METHODS

The study was a single-center, prospective, open-label, parallel-group, randomized trial conducted over 12 weeks. The study enrolled 60 patients with diabetes-related dyslipidemia who were receiving care at a diabetic clinic within a tertiary care teaching center. Patients were randomized into two groups: group I received a daily dose and group II received an alternate-day dose of rosuvastatin. The primary endpoint was the percentage change in low-density lipoprotein cholesterol (LDL-C). Secondary endpoints included percentage changes in total cholesterol (TC), triglycerides (TGs), high-density lipoprotein cholesterol (HDL-C) levels, and adverse events over 12 weeks of treatment. Appropriate tests were applied, considering a significance level of p<0.05. Paired t-tests were used for within-group comparisons, unpaired t-tests for between-group comparisons, and the Mann-Whitney test was applied to evaluate differences in the percentage changes in lipid profile parameters. The study adhered to the International Council for Harmonisation & Good Clinical Practice (ICH & GCP) guidelines. Approval from the Institutional Ethics Committee (IEC) and informed consent (IC) were obtained.

RESULTS

There was reduction in serum TC, TG, LDL-C, and very-low-density lipoprotein (VLDL) levels and an increase in HDL-C levels in both groups. After 12 weeks, significant improvements in lipid parameters were observed in both treatment groups (p<0.05), with the daily dosing group showing slightly more significant improvements. There was a significant decrease in TC level (p<0.0001) in the daily dose regimen, while significant decrease in LDL-C level (p<0.0001) in the alternate-day regimen of rosuvastatin dosing. Common adverse events included dizziness, palpitations, myalgia, malaise, and uneasiness, with no serious adverse events reported.

CONCLUSION

Alternate-day rosuvastatin treatment demonstrated comparable efficacy and safety to a daily dosing regimen, with significant reductions in TC, TG, LDL-C, and VLDL levels and an increase in HDL-C level. The alternate-day regimen is economically advantageous and provides an alternative option for patients who are intolerant to daily statin therapy.